Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age

Brief Title

Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age

Official Title

Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine as Fifth Dose Booster in Children 4 to 6 Years of Age

Brief Summary

      Currently, there is no 5-component acellular pertussis vaccine licensed for the 5th dose in
      US children aged 4 to 6 years.This study is aimed at providing evidence of sero-protection,
      booster response and safety of this formulation as a 5th dose.

      Primary Objective:

      - To compare the immune responses of Tetanus toxoid, reduced diphtheria toxoid, and acellular
      pertussis (Tdap) Vaccine to Diphtheria, tetanus and acellular pertussis (DTaP) vaccine (all
      antigens) when each is administered as a 5th dose and given concurrently, to children aged 4
      to 6 years.

      Secondary/Observational Objectives:

        -  To compare the immune responses for pertussis antigens of Tdap Vaccine to DTaP vaccine
           (for pertussis antigens) when each is administered as a 5th dose and given concurrently,
           to children aged 4 to 6 years.

        -  To present the long-term immunogenicity at 1-, 3-, and 5-years post-vaccination after
           each long-term follow-up.

        -  To describe the safety profile following vaccine administration.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level

Condition

Tetanus

Intervention

Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)

Study Arms / Comparison Groups

 Group 1

Description:  DAPTACEL primed participants

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

1045

Start Date

April 2007

Completion Date

December 2009

Primary Completion Date

November 2009

Eligibility Criteria

        Inclusion Criteria :

          -  Healthy, as determined by medical history and physical examination.

          -  Aged 4 to 6 (< 7) years at the time of study vaccination on Day 0.

          -  Signed and dated informed consent form that has been approved by the Institutional
             Review Board (IRB) by the parent or legally authorized representative.

          -  Signed and dated informed assent form from the subject if required by the IRB.

          -  Able to attend scheduled visits at Visit 1 and Visit 2 and able to comply with all
             trial procedures. Subjects will be invited to participate in the long-term
             immunogenicity follow-up study but a commitment to participate in the long-term is not
             required as an inclusion criterion.

          -  Documented vaccination history of 4 previous doses of DAPTACEL according to the
             recommended national immunization schedule for Diphtheria, tetanus and acellular
             pertussis (DTaP).

        Exclusion Criteria :

          -  Participation in another clinical trial in the 4 weeks preceding the trial
             vaccination.

          -  Planned participation in another clinical trial during the original trial period.

          -  Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer
             chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic
             corticosteroids therapy.

          -  Systemic hypersensitivity to any of the vaccine components or history of
             life-threatening reaction to the trial vaccine or a vaccine containing the same
             substances.

          -  Chronic illness at a stage that could interfere with trial conduct or completion.

          -  Blood or blood-derived products received in the past 3 months.

          -  Receipt of any other vaccine within 30 days prior to study vaccination, or planning to
             receive another vaccine within 30 days before the Visit 2 blood draw (with the
             exception of the annual influenza vaccine).

          -  History of diphtheria, tetanus or pertussis infection (confirmed either serologically
             or microbiologically).

          -  Thrombocytopenia or bleeding disorder contraindicating intra muscular vaccination.
      

Gender

All

Ages

4 Years - 6 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Director, , 

Location Countries

Canada

Location Countries

Canada

NCT ID

NCT00467519

Organization ID

TD517

Responsible Party

Sponsor

Study Sponsor

Sanofi Pasteur, a Sanofi Company

Study Sponsor

Medical Director, Study Director, Sanofi Pasteur Inc

Verification Date

January 2014